NCT01734265

Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml).

Prospective, Open Uncontrolled Study to Evaluate the Safety of Depigoid With Two Pollen Combinations (Grasses/Olea and Grasses/Parietaria)2000DPP/ml in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Seasonal Asthma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later.

Detailed description

The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later. The treatment period consists, thus, of 4 weeks. Primary variable: •Number of subjects \[%\] suffering at least one immediate or delayed systemic reaction of grade 2 or higher during the 4-weeks treatment period \[grading according to the 2006 EAACI standards

Conditions

• Allergy
• Rhinitis
• Rhinoconjunctivitis
• Seasonal Asthma

Interventions

Type	Name	Description
DRUG	Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)
DRUG	Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-03-01
• Completion: 2013-04-01
• First posted: 2012-11-27
• Last updated: 2014-01-29

Locations

4 sites across 1 country: Spain